Product recalls

The Royal Canin recall hit us hard. Hypoallergenic is the prescription diet we use second most (after Royal Canin’s Calorie Control). Over fifty of our clients feed it to as many as 100 of our patients. On Friday we sent out thirty-nine sets of bloodwork to Antech, almost what we’d expect to perform in a full month. We had another thirteen cats scheduled to come in for testing on Saturday. We’re performing urinalyses in house and sending out for CBCs and general chemistry profiles. I expect our bill to Royal Canin (who told us they will pay for testing of any cat that has eaten Hypoallergenic in the past six months) to be in the $8,000–$10,000 range, not including treatment costs for those cats showing signs of renal failure (so far, at least two) and not including overtime costs for our staff who have worked extra-long hours the past few days.

Royal Canin’s Handling of the Recall
Catmanager’s wife contacted our Royal Canin representative about three weeks ago to report a cat she had seen in early February with unusual urine crystals. The cat had slightly elevated BUN and creatinine (but still within normal range), had been vomiting, and was generally ADR. Fast forward several weeks and those odd crystals were popping up all over the country, now identified as melamine (Antech has a nice PDF with nine photographs). When my wife realized what she’d likely been seeing, she called our Royal Canin rep. The cat had been eating Hypoallergenic. Our rep said he was unaware of any problems but advised my wife to contact one of the company’s staff veterinarians.

Now that Royal Canin has recalled Hypoallergenic (along with a few other diets) because it contains tainted rice protein, we really wish my wife had made that second call (the birth of our first child got in the way). Had she talked with one of Royal Canin’s vets, would they still have reported “we have no confirmed cases of illness in pets” in their press release announcing the recall?

Probably yes, because a “confirmed” case is worlds away from a “suspected” case. Although I find the semantic game frustrating, it’s a small annoyance in what seems to be an otherwise forthright and responsible response—certainly Royal Canin has outperformed Hill’s in handling the recall. Unlike Hill’s, our Royal Canin rep contacted us immediately about the recall. We also didn’t have to wait for days for them to announce that they’d reimburse for testing. We were simply told that testing would be covered as long as we could show that the client had purchased a bag of recalled food within the last six months.

The response on the two companies’ Web sites is also quite different. Royal Canin’s front page is currently all about the recall. You can’t miss it. If one were unaware that Hill’s products had been recalled and visited the main page of their Web site, one would leave still unaware (unless one read the “Letter to Pet Owners” that is linked to from the main page). The page instead implies that Hill’s foods are unaffected by the recall: “Feed with Confidence.” “Wheat Gluten Free.” “Hill’s products not affected by rice protein concentrate recall.”

(We don’t use any P&G or Purina products, so I haven’t been as aware of their responses. Checking quickly, I don’t see any mention of the recall on Iams’ U.S. page. Purina addresses the recall on its main page.)

For several years now, my wife’s confidence in Hill’s products has steadily declined. For at least the past eighteen months she has refused to carry most of their maintenance diets. She finds that the Royal Canin prescription diets are generally more effective (k/d and z/d are the only Hill’s Prescription Diets we regularly use). Now, after watching them respond poorly over the last month to the pet food recall, her confidence has plumeted to new lows, and we’re seriously considering carrying only k/d and z/d.

Royal Canin, itself not free of warts (we’ve complained loudly in the past about poor communication from them), does at least seem to handle recalls well, admitting the problem in a timely manner and not shying away from their fiscal responsibility.

The story explains that “the American Association of Veterinary Laboratory Diagnosticians, in consultation with the Food and Drug Administration, was refining a working definition” of what consitutes a “case” of food-recall-related illness. As part of their effort, the AAVLD has set up an online survey (available on the AAVLD Web site and conducted by Michigan State University and the University of Guelph on behalf of the AAVLD) to collect incidents that diagnostic laboratories or veterinarians suspect are related to the food recall.

The AAVLD will share data with the FDA and will present an analysis of the data at the October 2007 AAVLD meeting.

Catmanager was excited to hear about the AAVLD survey, but after checking it out I was somewhat confused.

First
What is the purpose of the survey? Veterinarians have already been encouraged to report incidents to the FDA, their state veterinarian, and (if they are members) to VIN. Now they need to submit to another organization? Already taxed for time, why would they contribute to AAVLD?

According to the AVMA, the primary goal of the survey

is to distinguish true cases of nephropathy unique to this recall, hopefully resulting in a set of criteria defining a true case.

Other survey objectives are to characterize the spectrum of lesions; the temporal and geographic distributions of the suspected intoxications; the species, breeds, and ages of affected animals; and when possible, the brands, lot numbers, and UPC numbers of pet food involved in the toxic exposure, and results of chemical analyses.

Catmanager interprets this to mean that the AAVLD isn’t in the business of counting cases. They aren’t trying to create an authoritative tally (that’s up to the FDA). Instead, they’re trying to figure out how one should go about counting cases. In an e-mail responding to my questions, survey coordinator Dr. Wilson Rumbeiha seemed to confirm this interpretation.

The main objective is to define a true case of pet-food-induced nephrotoxicity derived from several criteria including history of ingestion of contaminated pet foods, documentation of renal failure by chemistry assays and urinalysis, histopathologic signs consistent with pe-food-induced nephrotoxicity and chemistry tests for markers of contaminants found in food, tissues and/or urine. Everyday animals fall sick or die of acute renal faliure and so our job is to come up with criteria that decide what is in and what is out.

Second
Who should be submitting data to the survey? The survey is publicly accessible and doesn’t require registration or passwords. According to Dr. Rumbeiha, the openness of the survey “is meant to encourage participation rather than discourage.” However, some of the

information asked for in the survey is not what you would expect regular veterinarians to have. That information would be gathered at diagnostic laboratories or selfstanding commercial labs like IDEXX. Hence we expect that only terminal diagnosticians will complete the survey as primary practitioners will not have the information handy.

Looking over the survey questions, catmanager suspects primary practitioners could answer all of the questions (in fact, many of the questions about patient history will be more easily answered by the primary practitioner unless they provide extremely detailed histories to the labs) but might not be able to fully answer question 9, which asks about crystal composition. The average practitioner will need to rely on labs to confirm the presence of melamine in the pet’s food or tissues, for example.

Still, I wondered about the openness of the survey. I can without difficulty imagine pet owners attempting to complete the survey. Would the researchers screen out data submitted by laypersons? Dr. Rumbeiha indicated that they will, and he pointed to the unique animal ID (such as a case number assigned by a lab) and contact information asked by the survey. Dr. Rumbeiha and three other pathologists will contact “each and every case entered” using that contact info. Any unauthenticated cases will be discarded from the survey.

Third
Will the survey, which was released on April 4, be updated to include the foods subsequently added to the recall? Dr. Rumbeiha said no, they’ll rely on people using the spot for “other” in the list of foods. This holds open the possibility that the survey could identify new foods in need of recall, although it’s not certain whether that information would be identified soon enough to have a practical effect.

Fourth
When can we expect to see results of the survey? After one or two months, the survey will close so that the team contacting the cases, reviewing slides, and checking the data has enough time to complete their work before the fall presentation to the AAVLD. Because the AAVLD commissioned the survey, they get to decide when and how they’ll release the data to the public. Dr. Rumbeiha wasn’t sure when that might be. He also wasn’t sure when or how the data would be shared with the FDA, but he did say they wouldn’t be sharing data in real time.

Our job is to define criteria of what is a real case of pet food poisoning and what is not. . . . the real work will follow the survey where pathologists will come up with these criteria defining what is in and what is out. That requires time and good scientific review.

So, check with your diagnostic lab to see whether they’re submitting reports to the AAVLD survey. If they’re not, consider submitting them yourself. (Pet owners, please save yourself and the researchers conducting the survey some time and don’t try to submit data yourself. You might, however, want to check that your veterinarian is aware of survey—many veterinarians aren’t members of AAVLD, and the AVMA news story announcing the survey won’t be published in print until the May 1 issue of JAVMA.)

As Pet Connection noted last week, this survey could serve as a model for a future reporting mechanism. One thing that struck catmanager was how simple setting up the survey appeared to be. It’s hosted at SurveyMonkey.com, which is one of many online survey companies that make it surprisingly easy—and inexpensive—to create your own survey. Of course, someone has to review the data (which presumes people have taken the time to submit data), and as Dr. Rumbeiha noted in his e-mail to me, the real work doesn’t start until the data are all in.

Still, from a technological standpoint, setting up a national adverse-events database for veterinary medicine should be doable with existing, commericially available software. Finding money for the real work of reviewing all the data is where the political will is needed.

The statement expresses condolence to pet parents whose pets have been “adversely affected by the recent pet food contamination incident.” (Incident is an interesting term to use for an ongoing problem.)

It argues that the “ever-changing news about the pet food recall” and its media portrayal

has created confusion and panic . . . and allowed for wild speculation about the safety and wholesomeness of commercial pet foods in general and mistrust of both the industry and government oversight of the industry.

It notes the college’s confidence that everything possible is being done to “identify the source of contamination and isolate pet foods affected by the contamination” and further notes that this process takes time.

It makes the sensible comment that “Contrary to the assertions of some, it simply is not in the best interest of companies to want to sell potentially unsafe product.”

It urges caution among those inclined to start feeding their pets home-prepared foods.

Overall the statement is, as the Pet Food Blog notes, a “voice of reason.”

Dr. Dan at The Happy Healthy Horse catches an amusing AP story about an RUI: riding under the influence.

Another horse doc, Dr. Alan Weldon, shares his recent experience working on a zebra and elephant at the Jacksonville Zoo.

Tasmiya compares the respect physicians get with the attitudes veterinarians sometimes face.

Patients waiting for their G.P. can often wait for over an hour and nobody complains. It’s just expected that they will have to wait. If vets are running 15 minutes behind, we must apologise profusely and placate many an angry client. I know everyone has busy lives and things to do and nobody wants to sit around for longer than they absolutely have to but sometimes we will have an emergency or urgent case to attend to and so normal vaccinations and ear cleans will have to wait.

As Tasmiya acknowledges, most people understand this—but the ones who don’t sure can make for an interesting day. Actually, I think it’s a credit to the profession that most veterinarians are so conscious of their clients’ time. Just one more way the veterinary community rises above our human medicine counterparts!

A (human) surgeon comments on the environmental impact of surgery. Not pretty. All but One Species, who found this interesting post, notes that the reality in vet med isn’t much different. Catmanager concurs.

Forbes has a great commentary on the response of pet food manufacturers to the recall crisis (thanks PetConnection!).

The home pages of Hill’s Pet Nutrition, Del Monte Foods and Nestlé Purina PetCare offered links to press releases that sound like the product of a chemist, a lawyer and a publicist huddled around a conference table.

From the article’s list of recommendations:

Third, stop being defensive. Simply reassuring people your other products are safe isn’t very reassuring. After all, a few weeks ago, you were de facto assuring that all your products were safe. Do you trust the guy who says “just trust me” right after he messed up? Probably not. To regain consumers’ trust, pet food brands have to give consumers reasons to trust that their food is safe.

Hill’s appears to have heard the loud chorus of veterinarians upset about their handling of the m/d recall and their initial refusal to offer to pay for testing of affected cats. Here’s the letter from the president of Hill’s:

As you know, Hill’s makes all its products with an overriding commitment to the health and well being of pets. With that in mind, on March 30, we notified you of our decision in conjunction with the FDA to issue a precautionary voluntary recall of a single product, Prescription Diet® m/d® Feline dry pet food, our only product containing the wheat gluten at issue other than the earlier recalled Science Diet® Savory Cuts® pet food. A list of recalled products is available on our website, http://www.hillspet.com. This recall was done in an abundance of caution, as the FDA has not yet been able to determine a cause for any pet illness.

However, to further reinforce our commitment to both pets and the veterinary profession, Hill’s is announcing a plan to offset medical screening costs you have incurred to support your clients who have purchased Prescription Diet m/d Feline dry pet food from January 2007 to the present.

Hill’s has decided to take this action to help support so many in the profession who have already extended themselves to assist their clients during this difficult time.

The program will provide a one time payment of $100 per patient tested. This is being made available to help offset the costs of standard tests that would otherwise be borne by your client or yourself. In the case of tests previously conducted, it is up to you to reimburse your clients for out of pockets costs up to $100. This payment shall be available for all requests thru May 30, 2007.

Hill’s Pet Nutrition would like to thank each of you for your on-going support of the Prescription Diet business and encourage you to take advantage of this offer.

The University of Guelph Laboratory Services department has posted images of crystals taken from a cat suspected to have ingested melamine-tainted food. Guelph hasn’t been able to identify the cystals yet, but mass spectrometry shows them to be 30 percent melamine and to have a different spectrum than ammonium urate or xanthine. Several veterinarians on VIN are reporting seeing crystals similar to those posted by Guelph.

Three articles in the press about pets and lawsuits. The first two are about lawsuits against Menu Foods. The last is about that currently rare (but soon to flourish) species, the malpractice suit against a veterinarian.

“Pet Owners Likely to Get Little in Suits”
The AP suggests class-action lawsuits might be the better option for pet owners affected by the pet-food recall. Unfortunately, the AP doesn’t do a good job explaining why this is so (or even whether the title of the story refers to class action or individual suits). The story accurately notes that in most states pets are legally considered personal property.

That means that even for the loss of a faithful family companion, a successful civil lawsuit would not likely produce much reward, said Carl Tobias, a law professor at the University of Richmond.

“With animals, all you get is the value of the property,” he said. “There are no emotional damages.”

Okay. So why then would banding together in a class action produce a better outcome for pet owners? The AP never says. Catmanager’s opinion (note: although I worked for two years in the law library of a major New York law firm, I have no legal training) is that while a class action would almost certainly benefit attorneys (who would take 30–50 percent of any monetary judgment), the benefits to plaintiffs are possible but far from guarranteed. First, the cost-benefit analysis. The cost of participating in a class action will likely be lower for individual pet owners than filing individual lawsuits. If awards are limited to the replacement value of the pet, which will be negligible for most non-pedigree animals, plus (possibly) the cost of veterinary care, then pet owners in a class action that reaches a verdict might see anywhere from $25 (if only replacement value of the pet is awarded) to $2500 (if veterinary bills are reimbursed, assuming vet bills of $5000, which is probably a high figure). However, as the emphasis in the previous sentence is meant to suggest, pet owners need to consider the possibility that a class action will result not in a jury verdict and award but instead a negotiated settlement. Attorneys often have more incentive to settle than to see a trial through to verdict. By settling, they get paid for sure (filing a class action doesn’t mean you’ll win). They get paid sooner rather than (possibly much) later. They incur far less risk for still significant gain. (Imagine 1000 pet owners with average vet bills of $5000 sign on to a class action. Assume that a successful trial would only recover the vet bills. That’s $5 million. The attorneys take 50 percent or $2.5 million. What incentive do they have to go through the expense and uncertainty of a full trial, however, if they can settle for $4 million or even $3 million? So they make a million less: $1.5 million in hand is better than $2.5 million in the bush.) Still, the cost of an individual hiring a lawyer to sue a large corporation would almost certainly far exceed any likely monetary award. In some states, the replacement cost of a pet and its associated vet bills might not even rise about a small-claims action. Oddly, some pet owners might be more successful filing small-claims actions. Doing so does not necessarily require a lawyer (court clerks will often walk you through the process) and is therefore usually far less expensive. And the prospect of having to respond to thousands of small-claims actions across North America might drive Menu Foods and the other responsible parties to offer a settlement directly to pet owners.

Two factors (at least) complicate my analysis. One is the possibility that some pet owners will be motivated to sue not by the possibility of monetary awards but because they wish to send a message and do something to help prevent similar problems from occuring in the future. The other is the possibility that judges and/or juries will decide that pets do deserve to be treated as more than personal property. If this happens (currently only Illinois and Tennessee have laws allowing judges and juries to award damages for emotional loss in cases involving pets), all bets are off.

“Putting a Price on Pet Grief”
A story in yesterday’s Chicago Tribune discusses the prospects of the Menu Foods lawsuits in light of the trend toward greater state recognition of the emotional links between pets and pet owners. One issue the article points out is that of jurisdiction in the Menu Foods lawsuits:

State laws are important because there are no federal statutes that define how claims of personal injury are to be compensated.

In the federal class-action lawsuits filed against Menu Foods, a judge eventually will have to decide which underlying state law applies. Most of the contaminated food was made in Menu’s plant in Emporia, Kan., according to the federal Food and Drug Administration.

Another type of claim that we might be hearing more about is the “loss of companionship” claim.

Some courts also have allowed another type of claim, known as “loss of companionship,” which recognizes that wrongful conduct damages not only the pet or the owner, but also their relationship.

Legislation is pending in Oregon, New York, Florida and Vermont that would address such claims.

This concept seems to catmanager to be a more happy medium. Clearly, laws that equate pets with inanimate property such as sofas and baseball bats are outdated. Giving animals the same rights as people is also problematic. Acknowledging the special relationships that do exist between people and pets (special, at least, to us; obviously we can’t ask our dogs and cats whether they find their relationships with us to be special, indifferent, or annoying) seems to me to be a reasonable compromise.

“Rare Veterinary Malpractice Suit Goes to TrialThe Record, a New Jersey paper, reports on a malpractice suit against a veterinarian. The case involves a cat that died under anesthesia. The plaintiffs argue that the defendants improperly intubated the cat, causing it to suffocate. The plaintiffs signed a consent form prior to the anesthesia.

Veterinary malpractice cases are rare. Only about 100 cases are filed nationally each year and hardly any make it to trial, according to the plaintiffs and their attorney, Gina Calogero, a member of the Animal Law Committee of the New Jersey State Bar.

“Usually, the expenses are too great and the damages are too low to justify going to trial,” Calogero said outside court. New Jersey law does not allow pet owners to sue for emotional distress in veterinary malpractice cases such as this, she said.

In this case, Calogero tried to sue for the “intrinsic value” of the cat, which she defines as “‘something more than fair market replacement value and less than sentimental value.'” The judge in the case decided that only replacement value could be awarded if the jury found negligence.